Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02251275
• Date of registration: 25/09/2014
• Prospective Registration: Yes
• Primary sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Public title: Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
• Scientific title: A Phase 3b, Multi-center, Open-label Trial to Evaluate the Long Term Safety of Immediate-release Tolvaptan (OPC-41061, 30 mg to 120 mg/Day, Split Dose) in Subjects With Autosomal Dominant Polycystic Kidney Disease
• Date of first enrolment: October 17, 2014
• Target sample size: 1803
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02251275
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Canada, Czech Republic, Czechia, Denmark, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, United Kingdom, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female participants = 18 years with confirmed diagnosis of ADPKD (during
participation in prior tolvaptan trials) who have completed and transferred from the
double-blind Trial 156-13-210 (12-month period including post treatment follow-up,
regardless of whether this was on-treatment or off-treatment), or completed Trial
156-08-271 or a prior tolvaptan trial, or interrupted or discontinued treatment in a
prior tolvaptan ADPKD trial other than Trial 156-13-210. Participants may be enrolled
with the medical monitor approval, and additional close monitoring may be required at
the beginning of the trial.

- eGFR = 20 milliliter (mL)/minute (min)/1.73 meter squared (m^2) within 3 months prior
to the baseline visit. Participants who have an eGFR = 20 mL/min/1.73 m^2 may be
enrolled with medical monitor approval.

Exclusion Criteria:

- Need for chronic diuretic use

- Hepatic impairment based on liver function abnormalities other than that expected for
ADPKD with cystic liver disease

- Women of childbearing potential who do not agree to practice 2 different methods of
birth control or remain abstinent during the trial and for 30 days after the last dose
of investigational medicinal product (IMP)

- Women who are breast-feeding and/or who have a positive pregnancy test result prior to
receiving IMP.

- Participants with contraindications to required trial assessments (contraindications
to optional assessments, for example, magnetic resonance imaging [MRI] are not a
limitation).

- Participants who in the opinion of the investigator or the medical monitor, have a
medical history or medical finding inconsistent with safety or trial compliance



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Polycystic Kidney, Autosomal Dominant

Intervention(s)

Drug: Tolvaptan

Primary Outcome(s)

Number Of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) [Time Frame: Baseline through end of treatment (up to 42 months) and follow-up 7 days posttreatment(+ 7 days)]

Secondary ID(s)

156-13-211

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/11/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02251275